Oxaliplatin and Fluorouracil Plus Radiation Therapy in Treating Patients With Primary Esophageal or Stomach Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining oxaliplatin and fluorouracil plus radiation therapy in treating patients who have primary esophageal or stomach cancer.
|Esophageal Cancer||Drug: fluorouracil Drug: oxaliplatin Procedure: conventional surgery Radiation: radiation therapy||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of Oxaliplatin in Combination With Continuous Infusion 5-Fluorouracil and Radiation in Esophageal Cancer|
|Study Start Date:||January 2000|
|Study Completion Date:||January 2004|
- Determine the maximum tolerated dose and dose-limiting toxicity of oxaliplatin when given in combination with continuous-infusion fluorouracil and radiotherapy in patients with primary cancer of the thoracic esophagus or gastroesophageal junction.
- Determine the pharmacokinetics of this regimen in this patient population.
- Assess somatic p53 mutations in cancer of the esophagus and determine their relation to therapeutic response induced by this regimen.
- Assess, in a preliminary manner, the efficacy of this regimen in these patients.
OUTLINE: This is a dose-escalation study of oxaliplatin and fluorouracil.
Patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and fluorouracil IV continuously on days 8-42. Patients also undergo radiotherapy once daily, 5 days a week, for 6 weeks beginning on day 8.
Patients without evidence of distant disease or unresectable local regional invasion undergo esophageal resection between days 63-70 (within 3-4 weeks after completion of chemoradiotherapy). Patients then receive oxaliplatin as above on days 105, 119, and 133 and fluorouracil as above on days 105-147.
Cohorts of 3-6 patients receive escalating doses of oxaliplatin and fluorouracil until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 4 weeks.
PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study within approximately 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004257
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Study Chair:||Lawrence P. Leichman, MD||Albany Medical College|